Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.
Checked against the public recordLast updated Mar 27, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: cisplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium; Drug: vinorelbine tartrate; Procedure: standard follow-up care
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma) * Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0 * No status * Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan * The mass must have a source document to verify tumor size in the greatest dimension, which includes a CT scan report, a clinic note from the enrolling physician, and/or a printed image with caliper measurements on the lung mass * Node-negative disease * Evidence of hilar or mediastinal node involvement by chest CT scan (\> 1 cm diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling before or at time of thoracotomy * No locally advanced or metastatic disease PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Granulocytes ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Bilirubin ≤ 1.5 mg/dL * AST \< 1.5 times upper limit of normal (ULN) * Serum creatinine ≤ 1.5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No history of prior or concurrent malignancy, except curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease-free for 3 years PRIOR CONCURRENT THERAPY: * More than 3 years since prior cytotoxic or anticancer treatment * No concurrent treatment with hormones or other chemotherapeutic agents, except steroids given for adrenal failure, hormone administered for nondisease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic * No concurrent thoracic radiotherapy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Regional Medical CenterAnniston, Alabama
- UAB Comprehensive Cancer CenterBirmingham, Alabama
- Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California
- Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, California
- Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
- Study locationPismo Beach, California
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California
- Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida
- Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida
- Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida
- CCOP - Mount Sinai Medical CenterMiami Beach, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 27, 2017. Always confirm current availability with the study team.